Research programme: antiviral therapeutics - Cocrystal Pharma/Kansas State University Research Foundation
Alternative Names: Mpro protease inhibitors - Cocrystal PharmaLatest Information Update: 08 Dec 2021
At a glance
- Originator Kansas state university research foundation
- Developer Cocrystal Pharma Inc; Kansas state university research foundation
- Class Antivirals; Small molecules
- Mechanism of Action Peptide hydrolase inhibitors; Virus replication inhibitors
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Preclinical Coronavirus infections; COVID 2019 infections; Norovirus infections
Most Recent Events
- 01 Dec 2021 Cocrystal Pharma Inc plans a phase I trial for COVID-2019 infections (In volunteers) (PO), in 2022
- 01 Dec 2021 Cocrystal Pharma Inc plans a phase II trial for COVID-2019 infections (PO), in 2022
- 18 Oct 2021 Preclinical trials in Norovirus infections in USA (PO) (Cocrystal Pharma pipeline, October 2021)
Development Overview
Introduction
Small molecule, broad spectrum, oral antiviral compounds are being developed by Cocrystal Pharma, under a license from Kansas state university research foundation, for the treatment of Norovirus (including gastroenteritis) and COVID-2019 infections. Cocrystal Pharma utilises a structure-based drug discovery technology which provides a 3D structure of inhibitor complexes at near-atomic resolution. This provides immediate insight to structure-activity relationships (SAR) resulting in identification of novel binding sites. Rapid turnaround of structural information is thus possible through highly automated X-ray data processing and refinement. By utilising this technology, Cocrystal is able to develop compounds that specifically target the coronavirus 3C-like protease (3CLpro), an enzyme that is important for viral replication. Preclinical development for COVID-2019 infections and early research for the treatment of norovirus is underway in the US.
CDI 45205 is the lead candidate from the research programme [see Adis Insight Drug profile 800063380].
Cocrystal Pharma is seeking opportunities for collaborations for the advancement of the programme [1] .
Company Agreements
In April 2020, Cocrystal pharma expanded its licensing agreement with Kansas State University Research Foundation to include rights to additional preclinical leads and to develop broad-spectrum antiviral compounds for the treatment of COVID-2019 infections. Earlier in March 2020, Cocrystal pharma acquired the patent rights from Kansas State University Research Foundation. Both the companies had entered into a licensing agreement with Kansas State University Research Foundation (KSURF) in February 2020, for the development of antiviral compounds for the treatment of Norovirus and COVID-2019 infections. Under this agreement, Cocrystal will receive exclusive, royalty-bearing right and license to antiviral compounds for humans covered by KSURF’s patents. Cocrystal intends to pursue preclinical and clinical development of theses antiviral compounds. Cocrystal will further advance its antiviral programs significantly by providing potent compounds for further development. [2] [1] [3]
Key Development Milestones
In March 2023, Cocrystal Pharma announced that their lead oral candidate will be selected by mid-2023 [4]
In November 2021, Cocrystal Pharma reported that oral protease inhibitor demonstrated potent in vitro pan-viral activity against human common coronaviruses, rhinoviruses, and respiratory enteroviruses that frequently cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis [5] .
In August 2021, Cocrystal Pharma plans a pre-IND meeting with the US FDA for an oral protease inhibitor in the first half of 2022 [6]
As at June 2021, preclinical development of the antiviral therapeutics for norovirus (including gastroenteritis) is underway (Cocrystal Pharma pipeline, June 2021).
In May 2020, Cocrystal Pharma reported that the additional compounds licensed from Kansas state university research foundation (KSURF) demonstrated in vitro and in vivo activity in animal models against the viral pathogens causing MERS and SARS, coronaviruses. Cocrystal initiated preclinical studies of COVID-19 inhibitors received from KSURF during quarter two of 2020 [7] [8] .
As of May 2020, Cocrystal Pharma reported that it plans to identify additional inhibitors using its proprietary platform technology in second and the third quarter of 2020. The company also plans to identify additional inhibitors from internal sources using its proprietary platform technology in quarter three of 2020 and anticipates the selection of its lead preclinical molecule in quarter four of 2020 [7] [8] .
In April 2020, Cocrystal released pharmacodynamics data from preclinical study of antiviral therapeutics for COVID-2019 infections [3] .
Early research for Norovirus infections is underway in the US [2]
Financing information
In May 2021, Cocrystal Pharma raised approximately $US 40 million in a public offering of the common stock. The company intends to use net proceeds for the expansion of its COVID-19 and influenza [see Adis Insight Drug Profile 800028956] treatment development programmes and general corporate purposes and working capital. In the same month, Cocrystal announced closing of the public offering [9] .
In August 2020, Cocrystal Pharma raised approximately $US 17.2 million in a public offering of common stock. The company intends to use the net proceeds for the expansion of its COVID-19 and influenza [see Adis Insight Drug Profile 800028956] treatment development programmes and general corporate purposes and working capital. Earlier in the same month the company announced com-mencement of the public offering [10] [11] .
Patent Information
As of March 2021, Cocrystal Pharma reported that the Norovirus and Coronavirus programmes' patent portfolio consists of three pending families of US provisional applications, and a portfolio of patent families licensed through KSURF [12] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation unspecified
- Class Antivirals, Small molecules
- Target Peptide hydrolase; Virus replication
- Mechanism of Action Peptide hydrolase inhibitors; Virus replication inhibitors
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WHO ATC code
J05A-X (Other antivirals)
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EPhMRA code
J5B9 (Antivirals, others)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Preclinical | USA | PO / unspecified | Cocrystal Pharma Inc | 01 Apr 2021 |
| Coronavirus infections | including MERS and SARS | - | Preclinical | USA | PO / unspecified | Cocrystal Pharma Inc, Kansas state university research foundation | 01 Apr 2020 |
| Norovirus infections | including gastroenteritis | - | Preclinical | USA | PO / unspecified | Cocrystal Pharma Inc, Kansas state university research foundation | 18 Oct 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Kansas state university research foundation | Originator | USA |
| Kansas state university research foundation | Owner | USA |
| Cocrystal Pharma Inc | Licensee | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Cocrystal Pharma Inc | - | Unspecified | - | 06 Mar 2020 |
Scientific Summary
Pharmacodynamics
Summary
In preclinical study, administration of antiviral compounds demonstrated significant increase in survival and reduced lung virus titer in the infected animals even when given one day after virus infection [3] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2022 | Trial Update | Cocrystal Pharma Inc plans a phase I trial for COVID-2019 infections (In volunteers) (PO), in 2022 [13] | 08 Dec 2021 |
| 31 Dec 2022 | Trial Update | Cocrystal Pharma Inc plans a phase II trial for COVID-2019 infections (PO), in 2022 [13] | 08 Dec 2021 |
| 30 Jun 2022 | Regulatory Status | Cocrystal Pharma plans a pre-IND meeting with the US FDA for orally available candidate in the first half of 2022 [6] | 25 Aug 2021 |
| 31 Dec 2020 | Trial Update | Cocrystal pharma plans to initiate preclinical studies for COVID-19 infections in the second half of 2020 [14] | 20 May 2020 |
| 31 Dec 2020 | Trial Update | Cocrystal Pharma plans to select a lead preclinical molecule from the COVID-19 coronavirus programme in the fourth quarter of 2020 [7] | 20 May 2020 |
| 30 Jun 2020 | Regulatory Status | Cocrystal Pharma intends to file patent application for COVID-2019 infections and Norovirus infections in the second quarter of 2020 [14] | 06 Apr 2020 |
| 30 Jun 2020 | Trial Update | Cocrystal Pharma plans to select a lead preclinical molecule from the Noravirus programme in the second quarter of 2020 [14] | 20 May 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 01 Dec 2021 | Trial Update | Cocrystal Pharma Inc plans a phase I trial for COVID-2019 infections (In volunteers) (PO), in 2022 [13] Updated 08 Dec 2021 |
| 01 Dec 2021 | Trial Update | Cocrystal Pharma Inc plans a phase II trial for COVID-2019 infections (PO), in 2022 [13] Updated 08 Dec 2021 |
| 18 Oct 2021 | Phase Change - Preclinical | Preclinical trials in Norovirus infections in USA (PO) (Cocrystal Pharma pipeline, October 2021) Updated 18 Oct 2021 |
| 16 Aug 2021 | Regulatory Status | Cocrystal Pharma plans a pre-IND meeting with the US FDA for orally available candidate in the first half of 2022 [6] Updated 25 Aug 2021 |
| 17 Mar 2021 | Patent Information | Cocrystal Pharma has patents pending for Norovirus and Coronavirus programmes in USA, before March 2021 [12] Updated 22 Apr 2021 |
| 14 May 2020 | Trial Update | Cocrystal Pharma plans to select a lead preclinical molecule from the COVID-19 coronavirus programme in the fourth quarter of 2020 [7] Updated 20 May 2020 |
| 22 Apr 2020 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Cocrystals [3] Updated 27 Apr 2020 |
| 01 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (PO), before April 2020 [3] Updated 27 Apr 2020 |
| 30 Mar 2020 | Trial Update | Cocrystal Pharma plans to select a lead preclinical molecule from the Noravirus programme in the second quarter of 2020 [14] Updated 20 May 2020 |
| 30 Mar 2020 | Trial Update | Cocrystal pharma plans to initiate preclinical studies for COVID-19 infections in the second half of 2020 [14] Updated 20 May 2020 |
| 30 Mar 2020 | Regulatory Status | Cocrystal Pharma intends to file patent application for COVID-2019 infections and Norovirus infections in the second quarter of 2020 [14] Updated 06 Apr 2020 |
| 11 Mar 2020 | Licensing Status | Antiviral therapeutics is available for licensing as of 06 Mar 2020 [1] Updated 11 Mar 2020 |
| 06 Mar 2020 | Licensing Status | Cocrystal Pharma acquired the patent rights from Kansas state university research foundation [1] Updated 11 Mar 2020 |
| 06 Mar 2020 | Trial Update | Cocrystal Pharma plans a preclinical and clinical trial in COVID-2019 infections and Norovirus infections [1] Updated 11 Mar 2020 |
| 25 Feb 2020 | Licensing Status | Cocrystal Pharma in-licenses antiviral compounds from Kansas State University Research Foundation [2] Updated 27 Feb 2020 |
| 25 Feb 2020 | Phase Change | Early research in Coronavirus infections in USA (PO) [2] Updated 27 Feb 2020 |
| 25 Feb 2020 | Phase Change | Early research in Norovirus infections in USA (PO) [2] Updated 27 Feb 2020 |
References
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Cocrystal Pharma Announces Plans to Advance Coronavirus Program.
Media Release -
Cocrystal Pharma, Inc. Announces License Agreement with Kansas State University Research Foundation for Norovirus and Coronavirus Antiviral Compounds.
Media Release -
Cocrystal Pharma Expands Exclusive License Agreement with Kansas State University Research Foundation to New Coronavirus Antiviral Compounds with Novel Mechanism of Action.
Media Release -
Cocrystal Pharma Reports 2022 Financial Results and Provides Updates on its Antiviral Drug Development Programs.
Media Release -
Cocrystal Pharmas SARS-CoV-2 Main Protease Inhibitors Demonstrate Pan-viral Activity against Human Common Coronaviruses, Noroviruses, Rhinoviruses, and Enteroviruses.
Media Release -
Cocrystal Pharma Reports Second Quarter 2021 Financial Results and Provides Antiviral Program and Milestone Updates.
Media Release -
Cocrystal Pharma Reports First Quarter 2020 Financial Results and Provides Updates on Antiviral Programs.
Media Release -
Cocrystal Pharma Provides COVID-19 Impact Update on Development Programs.
Media Release -
Cocrystal Pharma Announces Closing of $40 Million Bought Deal.
Media Release -
Cocrystal Pharma Announces Closing of $17.2 Million Bought Deal Including Partial Exercise of Underwriter's Option to Purchase Additional Shares.
Media Release -
Cocrystal Pharma Increases Previously Announced Bought Deal to $15.0 Million.
Media Release -
Cocrystal Pharma - SEC file December 2020. Internet-Doc 2021;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1412486/000149315221006211/form10-k.htm -
Cocrystal Pharma Presents Preclinical Data from COVID-19 Antiviral Programs and Outlines Near-Term Clinical Plans at the World Antiviral Congress 2021.
Media Release -
Cocrystal Pharma Reports 2019 Financial Results and Outlines Expected Value-Driving Milestones for 2020.
Media Release
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